Clinical trial · Interventional
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial
NCT04025164CI-TRIAL-00039566recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional fractionated Radiotherapy | Radiation | — | UNRESOLVED |
| Hypofractionated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiotherapy
- description
- 40 Gy/15 fractions irradiation is delivered to the whole breast, 2.67 Gy per fraction, 5 fractions weekly. Tumor bed is boosted to 48 Gy simultaneously, 3.2 Gy per fraction, 5 fractions weekly.
- interventionNames
- Radiation: Hypofractionated Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional Irradiation
- description
- 50 Gy/25 fractions irradiation is delivered to the whole breast, 2 Gy per fraction, 5 fractions weekly. Additional 10 Gy/5 fractions is boosted to tumor bed sequentially, 2 Gy per fraction, 5 fractions weekly.
- interventionNames
- Radiation: Conventional fractionated Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age18-70 years * Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy * Receive breast conserving surgery with negative margins * Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed. * The tumor bed is labeled with clips and it can be drawn on the treatment planning system. * Pathologically confirmed invasive breast cancer * Pathologically stage is T1-3N0-3M0 * Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery * No distant metastases * No supraclavicular or internal mammary nodes metastases * No neoadjuvant chemotherapy * Fit for postoperative radiotherapy. No contraindications to radiotherapy * KPS≥80 * Signed informed consent Exclusion Criteria: * T4 or M1 breast cancer * Supraclavicular or internal mammary nodes metastases * Pathologically confirmed DCIS only without an invasive component * Bilateral breast cancer or historically confirmed contralateral invasive breast cancer * Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy * Multiple lesions can not be removed by single quadrantectomy * Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) * KPS ≤ 70 * Patients with severe non-malignant comorbidity in cardiovascular or respiration system * Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin * Previous radiotherapy to the chest wall or regional lymph node areas * Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis * Pregnant or lactating * Conditions indicating that the patient cannot go through the radiation therapy or follow up * Unable or unwilling to sign informed consent
References
Publications (1)
- DERIVEDJin K, Luo J, Yu X, Guo X. Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial. Radiat Oncol. 2024 May 27;19(1):62. doi: 10.1186/s13014-024-02449-y. PMID 38802888